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NCT00050778 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 334
- Enrollment target
NCT00050778: Completed Phase 2 study, sponsored by Genzyme, a Sanofi Company.
NCT00050778 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 334 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050778, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 334 participants
- Enrollment target
Study Summary
This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previously treated with MS therapies other than steroids. The study was conducted for an initial period of 3 years and a follow-up to 5 years or more.
Primary Outcome
EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseli
Interventions
- BIOLOGICAL Interferon beta-1a
- BIOLOGICAL Alemtuzumab 12 mg
- BIOLOGICAL Alemtuzumab 24 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2002-12 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00050778 record still lists
NCT00050778 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher).
The record links to 0 conditions, and to 3 interventions - of which Interferon beta-1a is the first listed.
NCT00050778 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00050778 about?
NCT00050778 is a clinical study titled "A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis". This was a Phase II, randomized, open-label, rater-blinded, three-arm study comparing two different doses of alemtuzumab (Lemtrada™) and one dose of subcutaneous (SC) interferon beta-1a (Rebif®) in participants with early, active relapsing-remitting multiple sclerosis (MS) who had not been previousl...
What is the current status of trial NCT00050778?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2002-12. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00050778?
The interventions under investigation include: Interferon beta-1a (BIOLOGICAL), Alemtuzumab 12 mg (BIOLOGICAL), Alemtuzumab 24 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00050778?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00050778's enrollment target sits among peer trials
334 143rd of 2000 higher than 1,857 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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